• Physical examination at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16 in the daily worst pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Average number of doses of rescue medication required per week (up to Week 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Clinical laboratory assessments (hematology, blood chemistry, PT/PTT, urinalysis) at Screening, Baseline, and Weeks 2, 4, 6, 12 and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Time to a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Vital sign measurements at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Time to a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Neurologic examination at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Total duration of response as defined by days with ≥50% reduction from Baseline in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Weight measurements at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the mBPI worst pain scores obtained at study visits. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change in the weekly Opioid Related Symptom Distress Scale at Weeks 2, 4, 6, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the mBPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the modified Brief Pain Inventory (mBPI) average pain scores obtained at study visits. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Total duration of response as defined by days with ≥30% reduction from Baseline in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Anti-Drug Antibody testing at Baseline and Weeks 4, 6, 12 and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Adverse events from time of first dose of study treatment through the last patient visit. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
• Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Average daily opioid consumption (up to Week 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4 and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

• Average daily opioid consumption (up to Week 12).
• Average number of doses of rescue medication required per week (up to Week 12).
• Change in the weekly Opioid Related Symptom Distress Scale at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
• Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12, in the mBPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits.
• Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, and 12.
• Change in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8 and 12.
• Adverse events from time of first dose of study treatment through the last patient visit.
• Physical examination at Screening, Week 8 and Week 16 (or at early termination).
• Neurologic examination at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).
• Vital sign measurements at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).
• Weight measurements at Screening, Week 8 and Week 16 (or at early termination).
• Clinical laboratory assessments (hematology, blood chemistry, PT/PTT, urinalysis) at Screening, Baseline, and Weeks 2, 4, 8, 12 and 16 (or at early termination).
• Human Anti Human Antibody testing at Baseline and Weeks 4, 8, 12 and 16 (or at early termination).
• ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4, and 16 (or at early termination).
• Change from Baseline to Weeks 1, 2, 4, 8 and 12 in the daily average pain intensity NRS score.
• Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12 in the daily worst pain intensity NRS score.
• Change from Baseline to Weeks 5-12 and 5-8 in the daily average pain intensity NRS score.
• Change from Baseline to Weeks 5-12 and 5-8 in the daily worst pain intensity NRS score.
• Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the modified Brief Pain Inventory (mBPI) average pain scores obtained at study visits.
• Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the mBPI worst pain scores obtained at study visits.
• Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
• Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
• Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.
• Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.
• Time to a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
• Time to a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
• Total duration of response as defined by days with ≥30% reduction from Baseline in the daily average pain intensity NRS score.
• Total duration of response as defined by days with ≥50% reduction from Baseline in the daily average pain intensity NRS score.

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

• Neoplasm Metastasis
• Palliative Care

• Drug: Tanezumab 10 mg IV
• Drug: IV Placebo for tanezumab

Inclusion Criteria:

• Prostate cancer or breast cancer that has spread to bone, causing moderate to severe bone pain.
• Requires daily opioid medication

Exclusion Criteria:

• Patients who do not have bone pain caused by cancer are not eligible for the study.
• Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.